Cuban Public Registry of Clinical Trials this Sunday just published a study that includes a new clinical trial with the «prophylactic vaccine candidate» against COVID-19, officially called «FINLAY-FR-1A», which would pass to be Soberana 01A.
At the moment, the information is quite preliminary and the new clinical trial aims to «evaluate the safety, reactogenicity and explore the immunogenicity of different formulations of the Prophylactic Vaccine Candidates against SARS-CoV-2, FINLAY-FR-1 and FINLAY-FR-1A «.
Once again, the Finlay Vaccine Institute in Havana is the institution that registers this vaccine formulation, with the announcement of a phase I study (evaluation of the safety of the formulation), with the so-called «Gold Standard» (Randomised controlled trials (RCTs) are regarded as the gold standard of scientific evidence, and for good reason. By randomising a treatment across study arms, RCTs eliminate patient-treatment selection bias, resulting in reliable causal inference) which is characterized by being randomized, double-blind, and adaptive.
According to the information published on the website of the Cuban Registry of Clinical Trials, this phase I of the study will take place between October 19 and November 9, in which three groups will participate.
One of the three groups would receive the announced Soberana 01, in high doses, on two occasions 28 days apart; while the new vaccine formulation would be applied in two other groups, respectively in high and low doses, with a 28-day interval in the case of the former, and a third application on day 56 of the last group.
The vaccine administration during the research is expected to «be safe, admitting no more than 5 percent of individuals with serious adverse events (SAEs) with a causal relationship consistent with vaccination,» according to the announcement.
The first formulation of SOBERANA 01 was presented last August and is in phases I and II of clinical trials with just over 700 volunteers, a process which has passed without adverse events.
On October 15, the website of the World Health Organization (WHO) that tracks the global race for vaccines, registered 42 vaccine candidates, including SOBERANA 01, the only one from a country in Latin America and the Caribbean.
(Translated by Yeney Perez Corona)
Equipo de editores del sitio web de Radio Ciudad del Mar.